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ACIST Showcases Hi-Definition IVUS System
Company Looking to Enter the IVUS Market Currently Dominated by Boston Scientific and Volcano
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ACIST Medical Systems, Inc.

ACIST HDi™ High-Definition Intravascular Ultrasound System
ACIST HDi™ High-Definition Intravascular Ultrasound System
October 8, 2014 -- At last month's Transcatheter Cardiovascular Therapeutics meeting in Washington, DC, a new high-definition intravascular ultrasound (IVUS) system was demonstrated as part of two live case broadcasts.

The system, manufactured by ACIST Medical of Eden Prairie, Minnesota, is billed as "hi-def" because it images at a frequency of 60mHz. Current systems in the U.S., manufactured by the market leaders Boston Scientific (NYSE: BSX) and Volcano Corporation (NASDAQ: VOLC) image at 20mHz, 40mHz and 45mHz (for Volcano's Revolution IVUS catheter).

The ACIST HDi system is currently FDA-approved and the company is looking at possible approvals in Japan and Europe for early 2015.

Intravascular ultrasound has been around since the early 1980s and is used in cath labs during stent placement as an imaging modality that gives more detailed and different kinds of information from that seen on standard angiography. A complete description can be found in the article, "What is IVUS?" found in Angioplasty.Org's Intravascular Guidance Center.

Another intravascular imaging modality, Optical Coherence Tomography or OCT, provides far greater surface resolution than IVUS, but lacks the depth imaging of IVUS which allows the interventionist to see into the layers of arterial wall and plaque and make an accurate assessment of the true lumen diameter. There are, however, a number of ways in which the very sharp OCT picture of the arterial surface can be very helpful, and preference for IVUS or OCT is the subject of ongoing debate at most interventional meetings.

Complicating the landscape further is another system, manufactured by Infraredx of Burlington, Massachusetts. Their TVC Imaging System combines both IVUS and near-infrared spectroscopy (NIRS) to detect lipid-core plaques. It currently is the only system approved by the FDA for this indication; it recently received approval in Japan as well. Japan has in fact been one of the largest markets for intravascular ultrasound imaging, mainly because the health care system in Japan, unlike the U.S., has reimbursed the use of IVUS for years.

Whether the addition of 15mHz of frequency and higher resolution imaging will allow ACIST to move successfully into the U.S. and international IVUS market is yet to be seen (Boston and Volcano currently split the U.S. market 50/50), but one factor might be the company's recently announced co-promotion agreement with medical device giant Medtronic to commercialize its IVUS and FFR offerings.

The press release from ACIST Medical Systems follows:

ACIST Launches HDi High-Definition IVUS
High-Definition Resolution, Faster Pullback and Innovative Touch Screen Display Advances IVUS for Cardiologists

September 17, 2014 -- Eden Prairie, Minnesota -- ACIST Medical Systems, Inc., a Bracco Group company, pioneer and global market leader of advanced imaging modalities for cardiology, showcased the first-ever HDi™ High-Definition Intravascular Ultrasound System in two live cases at the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C. The cases were presented from Medstar Washington Hospital Center (Washington, D.C.) and New York-Presbyterian Hospital/Columbia University Medical Center (New York, NY). The HDi features an intuitive touch screen with 60MHz image quality, high-speed pullback, a deliverable Kodama® HD-IVUS catheter and the ACIST HDi console. HD-IVUS is a reinvention of intravascular imaging.

The ACIST Medical Systems portfolio has recently expanded beyond the CVi contrast delivery system, to include Rapid Exchange FFR (RXi) and High-Definition IVUS (HDi) technologies. Through these products, ACIST is demonstrating its commitment to bringing unique and innovative technologies that simplify cardiovascular procedures and empower clinicians to treat patients with superior care.

"Improving patient outcomes by offering cardiologists innovative and improved tools is critical to our business," said Tom Morizio, President and COO, ACIST Medical Systems. "Our new HD-IVUS is a highly anticipated technology that offers improvements in an area that has lacked innovation for many years. Physicians tell us they appreciate that ACIST is raising the bar for IVUS performance."

The ACIST HDi IVUS system is easier to use and offers detailed insight that physicians can use to optimize treatment choice for their patients. The HDi provides improved image quality over traditional IVUS systems. During one of the live broadcasts from Columbia Medical Center, world-renowned imaging expert Dr. Akiko Maehara noted, "The ability to visualize plaque morphologies and intravascular structures in high definition is a welcome advancement in imaging."

Additionally, the simple, intuitive touch-screen display features 60MHz image quality, which enables easier identification and interpretation of intravascular structures and disease. The Kodama HD-IVUS catheter is deliverable and offers high-speed pullback that is 20 times faster than currently available IVUS systems—lowering the risk of catheter-induced ischemia by reducing pullback time from minutes to seconds.

"We believe it's our job to provide ongoing innovations for coronary cath labs that improve accuracy, speed, efficiency and delivery," said Dr. Robert Wilson, founder of ACIST Medical Systems. "To continually and dramatically improve technology that improves interventional cardiovascular medicine is our greatest commitment."

ACIST, a Bracco Group company, is a pioneer and global market leader of advanced contrast delivery systems for cardiology. By developing advanced diagnostic technologies that help simplify the complexities of the cardiac cath lab, it empowers clinicians and their teams in providing superior patient care. ACIST products are being used by cardiologists in more than 70 countries worldwide, and more than 15 million patients have benefited from a cardiovascular angiography procedure using an ACIST Contrast Delivery System.

ACIST is headquartered in Eden Prairie, Minn., with regional offices in Europe and Asia. A team of more than 300 people worldwide helps manage and support a portfolio of products and services that simplify and enhance contrast injection procedures. ACIST and its sister company, HLT — a medical device company dedicated to the development of transcatheter aortic valve technology — are part of the Bracco Group, an international leader in diagnostic imaging. Both companies share the same founder, president and COO and commitment to innovation in interventional cardiology. Together, they are setting new standards in the industry with the pursuit of emerging cardiology solutions, addressing clinical and physician needs to provide superior patient care. To learn more about ACIST, visit

About the Bracco Group
Bracco has headquarters in Milan, Italy, and was founded in 1927. It is active in the healthcare sector through Bracco Imaging (diagnostic imaging), Pharma (prescription and over the counter drugs), ACIST Medical Systems and HLT (cardiology) and the Centro Diagnostico Italiano diagnostic clinic. It has around 3,300 employees and annual total consolidated revenues of over 1.2 billion Euro. Bracco operates in more than 90 countries worldwide. To learn more about Bracco Group, visit

Reported by Burt Cohen, October 8, 2014